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Octafibrin
Octafibrin is a Small molecule drug developed by Octapharma. It is currently in Phase 3 development. Also known as: Plasma derived fibrinogen concentrate, Fibrinogen concentrate.
Octafibrin is a fibrinogen concentrate used to treat acquired hypofibrinogenemia, congenital fibrinogen deficiency, and afibrinogenemia. It is compared to cryoprecipitate and other fibrinogen products, such as Haemocomplettan P or RiaSTAP, in clinical trials for the treatment of these conditions.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Octafibrin |
|---|---|
| Also known as | Plasma derived fibrinogen concentrate, Fibrinogen concentrate |
| Sponsor | Octapharma |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery (PHASE3)
- Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency (PHASE3)
- FIBrinogen REplenishment in Surgery (PHASE3)
- Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Octafibrin CI brief — competitive landscape report
- Octafibrin updates RSS · CI watch RSS
- Octapharma portfolio CI
Frequently asked questions about Octafibrin
What is Octafibrin?
Who makes Octafibrin?
Is Octafibrin also known as anything else?
What development phase is Octafibrin in?
Related
- Manufacturer: Octapharma — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Plasma derived fibrinogen concentrate, Fibrinogen concentrate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing